We're seeking an experienced CMC Regulatory Consultant to provide strategic regulatory leadership for the development of an innovative therapeutic utilizing advanced oligonucleotide and targeted intracellular drug delivery technologies.This is an opportunity to work alongside a cutting-edge development team, helping shape CMC strategy from early development through IND submission while supporting groundbreaking science.Compensation: $250 per hour What You'll Do Provide strategic CMC regulatory guidance throughout product development. Review and advise on drug substance, drug product, manufacturing, analytical methods, and control strategies. Lead or contribute to IND CMC sections, FDA briefing packages, and regulatory responses. Identify regulatory risks and recommend practical mitigation strategies. Collaborate with cross-functional teams and CDMO partners to support successful development and regulatory milestones.RequirementsWhat We're Looking For Advanced scientific degree (PhD, PharmD, MS, or equivalent). 10+ years of CMC regulatory experience within pharmaceutical or biotechnology organizations. Deep expertise supporting oligonucleotide therapeutics (antisense oligonucleotides, siRNA, RNA therapeutics, or related technologies). Extensive experience authoring or reviewing IND CMC submissions. Strong knowledge of FDA CMC regulations and regulatory strategy. Experience working with CDMOs and multidisciplinary development teams. Preferred: Experience with targeted intracellular or endosomal drug delivery technologies. Prior FDA regulatory experience or senior CMC leadership. Background supporting successful IND submissions. If you're a strategic regulatory expert who thrives at the intersection of innovative science and regulatory excellence, we'd love to hear from you.BenefitsThis position does not qualify for benefits. MPF Federal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
We're seeking an experienced CMC Regulatory Consultant to provide strategic regulatory leadership for the development of an innovative therapeutic utilizing advanced oligonucleotide and targeted intracellular drug delivery technologies.
This is an opportunity to work alongside a cutting-edge development team, helping shape CMC strategy from early development through IND submission while supporting groundbreaking science.
Compensation: $250 per hour
What You'll Do
- Provide strategic CMC regulatory guidance throughout product development.
- Review and advise on drug substance, drug product, manufacturing, analytical methods, and control strategies.
- Lead or contribute to IND CMC sections, FDA briefing packages, and regulatory responses.
- Identify regulatory risks and recommend practical mitigation strategies.
- Collaborate with cross-functional teams and CDMO partners to support successful development and regulatory milestones.
Requirements
What We're Looking For
- Advanced scientific degree (PhD, PharmD, MS, or equivalent).
- 10+ years of CMC regulatory experience within pharmaceutical or biotechnology organizations.
- Deep expertise supporting oligonucleotide therapeutics (antisense oligonucleotides, siRNA, RNA therapeutics, or related technologies).
- Extensive experience authoring or reviewing IND CMC submissions.
- Strong knowledge of FDA CMC regulations and regulatory strategy.
- Experience working with CDMOs and multidisciplinary development teams.
Preferred:
- Experience with targeted intracellular or endosomal drug delivery technologies.
- Prior FDA regulatory experience or senior CMC leadership.
- Background supporting successful IND submissions.
If you're a strategic regulatory expert who thrives at the intersection of innovative science and regulatory excellence, we'd love to hear from you.
Benefits
This position does not qualify for benefits.
MPF Federal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
MPF Federal is a team of highly experienced professionals dedicated to our clients’ needs. Headquartered in Gaithersburg, MD and we serve both the Federal Government and commercial clients. Established in 2012, MPF is a SBA Certified HUB Zone and Woman Owned SDB, DUNS# 078461876.
Our diverse team of professionals draws on a mixture of results-oriented methodologies and business savvy that bridges the gap between client requirements and results. We set measurable, ambitious performance standards and produce rapid results. Whether located at our corporate facilities or at one of our customers’ locations, we focus on achieving and surpassing measurable objectives on time and within budget. We foster an environment that facilitates success in all of our core business areas.
MPF Federal is a team of highly experienced professionals dedicated to our clients’ needs. Headquartered in Gaithersburg, MD and we serve both the Federal Government and commercial clients. Established in 2012, MPF is a SBA Certified HUB Zone and Woman Owned SDB, DUNS# 078461876.
Our diverse team of professionals draws on a mixture of results-oriented methodologies and business savvy that bridges the gap between client requirements and results. We set measurable, ambitious performance standards and produce rapid results. Whether located at our corporate facilities or at one of our customers’ locations, we focus on achieving and surpassing measurable objectives on time and within budget. We foster an environment that facilitates success in all of our core business areas.
